Probiotics are live microorganisms which when administered in adequate amount can confer health benefits on the host. Probiotics promote a healthy balance of gut bacteria and have been linked to a wide range of health benefits. Another category of food additive which is beneficial to the human body is – Prebiotics. These are non-digestible ingredients which help in boosting the immune system of human body. Both prebiotics and probiotics help in boosting the immune system of human body and inhibit the growth of harmful gut bacteria, while promoting the production of natural antibodies in the body. In the current scenario of COVID-19, Probiotics/Prebiotics are considered critical to boost the immunity. But with the decline in the global supply chains of Probiotics/Prebiotics, meeting the demand right on time would be challenging.
To ensure the world sustain the international health crisis, as a Probiotics/Prebiotics probiotic manufacturer you might be willing to market your products across the globe or to be specific in the USA. Probiotics/Prebiotics, in the USA, are classified under Generally Recognized as Safe (GRAS) and are required to be notified to the United States Food and Drug Administration (US FDA). To exempt from the requirement of premarket approval of the Federal Food, Drug and Cosmetic act, manufacturers or distributors can submit a GRAS notice to the FDA.
Probiotics/Prebiotics – Freyr’s Regional Focus
With a vast knowledge on the US FDA and Probiotics/Prebiotics Regulatory requirements, Freyr team of subject matter experts (SMEs) can assist you with compliance check of the product’s registration, label and claims to identify if the product is able to comply to the requirements listed by the FDA or will need to submit NDIN/GRAS. If the client has to submit an application for NDIN or GRAS, Freyr team can assist you in preparing, compiling and submitting the complete application to FDA as per the regulations on approval for non – specified ingredients. Freyr is specialized in:
- Probiotics/Prebiotics registration in the USA
- Probiotics/Prebiotics market entry
- Evaluation of your label or labeling information for compliance
- Review of immunity boosting claims
- Design or develop artwork for Immunity boosters
- Review or assess the product formula to identify the product category and to check the acceptability of all the ingredients in the product in line with the US FDA
- Suggesting mandatory, missing information and nutritional/supplemental facts or the corrections to be made on the label of the product as per the country specific regulations
- Monitor compliance with US FDA including advising on general labelling and advertising issues, nutrition labelling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
- Prepare and submit dossier for Probiotics/Prebiotics registration
- Assist with devising a robust Regulatory pathway for your product
As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registrations of Probiotics/Prebiotics in the USA.